BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RCSP RETROGRADE CANNULA

    MDR report key: 19275731 · Received May 9, 2024

    Report

    Report Number
    2184009-2024-00279
    Event Type
    Malfunction
    Date Received
    May 9, 2024
    Date of Event
    May 8, 2024
    Report Date
    May 30, 2024
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    DWF
    UDI-DI
    00643169454736
    PMA / PMN Number
    K860149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.5. ADDITIONAL INFORMATION:MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP SILICONE RCSP CANNULA WITH MANUAL-INFLATE CUFF , IT WAS REPORTED THAT THE DEVICE HAD A PIN HOLE IN THE BALLOON. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO DAMAGE TO THE PACKAGING OR TO OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME, THIS DLP SILICONE RCSP CANNULA WITH MANUAL-INFLATE CUFF HAD A PIN HOLE IN THE BALLOON. THE USE OF THE DEVICE WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520484 RCSP RETROGRADE CANNULA CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO DWF PERFUSION SYSTEMS 94725 2023038010 00643169454736

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown